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| Name | Class |
|---|---|
| Novonesis | INDUSTRY |
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The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (probiotic Lactobacillus paracasei LP-33)(as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment.
Oral H1-antihistamines are first treatment recommended for allergic rhinitis (Bousquet et al, 2008) however they do not completely alleviate symptoms. This new study will therefore assess the effect of Lactobacillus paracasei LP-33 in the management of nasal and ocular symptoms, in addition to H1-antihistamines treatment. The main objective is to evaluate the effect of Lactobacillus paracasei LP-33 on quality of life. Additionally allergic rhinitis symptoms (nasal and eye symptoms) and immunological parameters will be evaluated, before and during the supplementation. Lactobacillus paracasei LP-33 is targeting the general population and improving quality of life of people sensitized to allergens. The study will be conducted in Europe on adult subjects with persistent allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tested product: Lactobacillus paracasei LP-33 | Active Comparator | Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table |
|
| Comparative product : placebo | Placebo Comparator | Each patient will be randomly assigned to either tested product or comparative product (placebo) in accordance with a randomisation table . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Description: - capsule size 3 Composition of the product:
Composition of the capsule:
Packaging: Products are packaged in aluminium tubes of 30 capsules. Storage: The product should be stored in a fridge. Direction for use: subject should consume 1 capsule daily together with a meal, with a glass of water. The study products will be consumed daily for 7 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary criterion is the RQLQ global score measured at the end of Week 0 and Week 5. | The RQLQ includes 28 questions (completed between 10-15 min). Subjects are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale (0 = no impairment, 6 = severe impairment). The RQLQ score ranges from 0 to 6. This questionnaire will be filled in by volunteers on D0 and D35. The aim of the study is to show an improvement of quality of life on the 5th week of product consumption (as assessed by RQLQ global score) in subjects with persistent allergic rhinitis currently treated with Loratadine or oral anti-histaminic treatment. | Week 0 and Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| To show a decrease in allergic rhinitis symptoms on the 5th week of product consumption (as assessed by RQLQ and RTSS-5) | Week 0-Week 5 | |
| To show an increase in the time of 1st exacerbation of symptoms of rhinitis symptom with Lactobacillus paracasei LP-33 |
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Inclusion Criteria:
Female subjects with efficient contraception and asthmatic subjects (with a controlled disease and without oral corticosteroid) can be included in the study.
The baseline period prior to treatment with Lactobacillus paracasei LP-33 is 7 days. On recommendations of the consulted experts, Pr Bousquet and Pr Hamelmann, a wash-out period of 3 additional days is recommended before baseline for subject using intranasal corticosteroid before their inclusion. As a consequence, the baseline may be extended to 10 days for these subjects In case the subject consumed an anti-H1 (other than Loratadine) before his (her) inclusion, he (she) will have to switch to Loratadine to be included.
Exclusion Criteria:
Taking part in another clinical trial or being in the exclusion period of a previous clinical trial;
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| Name | Affiliation | Role |
|---|---|---|
| Jean BOUSQUET, Pr | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corinne SION | Aix-en-Provence | 13100 | France | |||
| Alain FAUDIN |
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|
| Lactobacillus paracasei LP-33 | Dietary Supplement | Description:
|
|
| Week 5- Week 7 |
| Alès |
| 30100 |
| France |
| Philippe PIAT | Alès | 30100 | France |
| Sylvie CHABROL-RIVIERE | Alès | 30100 | France |
| Daniel FERET | Aubevoye | 27940 | France |
| Florian KOMAC | Aubord | 30620 | France |
| Alain GIACOMINO | Avoine | 37420 | France |
| Jean DEFLAUX | Beaucaire | 30300 | France |
| Sébastien CONVENT | Beauvoisin | 30640 | France |
| Catherine BRUNET-CAZOT | Béziers | 34500 | France |
| Emmanuel DEJOUX | Béziers | 34500 | France |
| Gabriel VENTURINI | Béziers | 34500 | France |
| Nicolas BRETON | Béziers | 34500 | France |
| Robert COMBET | Béziers | 34500 | France |
| Thierry STEFANAGGI | Béziers | 34500 | France |
| Olivier BISCH | Bischeim | 67800 | France |
| Sabine GRUTTER | Bischeim | 67800 | France |
| Sophie ROSENBERG | Bischeim | 67800 | France |
| Jacques RAMBAUD | Bompas | 66430 | France |
| Chantal MARTIN | Bouillargues | 30230 | France |
| Catherine AYRAL | Boujan-sur-Libron | 34760 | France |
| Laurence DAGES | Bourg-Achard | 27310 | France |
| Dominique EDET | Bretteville-l'Orgueilleuse | 14740 | France |
| Didier CADINOT | Broglie | 27270 | France |
| François LE HINGRAT | Calvisson | 30420 | France |
| Bernadette CHAUFFAILLE | Castelnau-le-Lez | 34170 | France |
| Georges BINET | Castelnaudary | 11400 | France |
| Hervé VILAREM | Castelnaudary | 11400 | France |
| Gladys HAVARD | Clarensac | 30870 | France |
| Marc GARCIA | Clarensac | 30870 | France |
| Michel AMOUYAL | Codognan | 30920 | France |
| Nicole FERRIER | Codognan | 30920 | France |
| Philippe GRUJARD | Colombelles | 14460 | France |
| Philippe HEUZE | Cournonsec | 34660 | France |
| Gregoire MARTOCQ | Cournonterrac | 34660 | France |
| Bruno DAUBIN | Coursan | 11110 | France |
| Jean-Baptiste DE LEMOS | Damville | 27240 | France |
| Marcel RUETSCH | Dessenheim | 68600 | France |
| Christian DAUGENET | Équeurdreville-Hainneville | 50120 | France |
| Gérard DUGNY | Évreux | 27000 | France |
| Thierry CANALI | Évreux | 27000 | France |
| Frédéric RENOU | Fécamp | 76400 | France |
| Pascal MABIRE | Fleury-sur-Orne | 14123 | France |
| Alain LION | Gambsheim | 67760 | France |
| Raymond WESTERFELD | Hangenbieten | 67980 | France |
| Gérard TELLIER | Hautot-sur-Mer | 76550 | France |
| Marc BUR | Herlisheim | 67850 | France |
| Jean Pascal SASTOURNE | Ille-sur-Têt | 66130 | France |
| Reinhard RENNER | Laroque-des-Albères | 66740 | France |
| Christian FLAISSIER | Lasalle | 30460 | France |
| Irène LAFONT | Lasalle | 30460 | France |
| Patrick DUTILLEUL | Le Cailar | 30740 | France |
| Claude BRUNAUD | Lignan-sur-Orb | 34490 | France |
| Jean-Philippe RICHTER | Lingolsheim | 67380 | France |
| Stéphane BOURGHOL | Marguerittes | 30320 | France |
| Maurice GAY | Maurin | 34970 | France |
| Patrick OLOMBEL | Mèze | 34140 | France |
| Cécile BELIN-SAUGET | Montpellier | 30090 | France |
| Jean François GUILLEM | Montpellier | 34000 | France |
| Jean Roch ALEA | Montpellier | 34000 | France |
| Marie Pascale DEMOLY | Montpellier | 34000 | France |
| MONGIN | Montpellier | 34000 | France |
| Thierry AUTARD | Montpellier | 34000 | France |
| Victor BASTIDE | Montpellier | 34000 | France |
| Michel CHASSAGNE | Montpellier | 34070 | France |
| Philippe CAYRON | Montpellier | 34070 | France |
| Jean Pierre CANO | Montpellier | 34080 | France |
| Patrick VOGT | Mulhouse | 68200 | France |
| Jean-Louis WURTZ | Mundolsheim | 67450 | France |
| Nasser GOUCHENE | Nîmes | 30000 | France |
| Paul REGNIER-VIGOUROUX | Nîmes | 30000 | France |
| Claude BERNAT | Nîmes | 30900 | France |
| Dominique BLOT | Nîmes | 30900 | France |
| Marie Christine BONS-GALLET | Nîmes | 30900 | France |
| Philippe IMBERT | Nîmes | 30900 | France |
| COSTA | Nîmes | 30920 | France |
| Georgios MARKIDIS | Obernai | 67210 | France |
| Natacha HEITZ | Obernai | 67210 | France |
| Yves-Olivier SCHLECHT | Obernai | 67210 | France |
| Guy BIRRY | Ottrott | 67530 | France |
| Bernard PRIJAC | Pacy-sur-Eure | 27120 | France |
| Alain GUERRI | Perpignan | 66000 | France |
| Chantal MALZAC | Perpignan | 66000 | France |
| Gérard BOURREL | Perpignan | 66000 | France |
| Serge ELIE | Pompignan | 30170 | France |
| Sonia COURTOIS | Pont-de-l'Arche | 27340 | France |
| Bernard GABBAI | Pont-Saint-Esprit | 30130 | France |
| Geneviève DURANT | Rivesaltes | 66600 | France |
| Baudoin PINSON | Rouen | 76000 | France |
| Olivier BAISSAS | Rouen | 76000 | France |
| Dominique GENOUD | Rousson | 30340 | France |
| Sylvie OLLIVIER | Rousson | 30340 | France |
| Patrick VERDAVOINE | Rugles | 27250 | France |
| Béatrice LOGNOS-FOLCO | Saint-Georges-dOrques | 34680 | France |
| Catherine MERCEY | Saint-Génis-des-Fontaines | 66740 | France |
| Yves MERCEY | Saint-Génis-des-Fontaines | 66740 | France |
| Jean-Yves DOERR | Saint-Sébastien-de-Morsent | 27180 | France |
| Martine FERRE | Saint-Siffret | 30700 | France |
| Gil MEYRAND | Sainte-Anastasie | 30190 | France |
| Jean Baptiste THIBERT | Salses-le-Château | 66600 | France |
| Léa ABOAF | Schilttigheim | 67300 | France |
| Monique LESCOUTE | Schilttigheim | 67300 | France |
| Raymond ATTUIL | Schilttigheim | 67300 | France |
| Luc ECHINARD | Sète | 34200 | France |
| Laurent TENNEZE | Sommières | 30250 | France |
| Charles LOUSQUI | Strasbourg | 67000 | France |
| Claire PFRUNNER-SCHNEIDER | Strasbourg | 67000 | France |
| Claire ROLLAND-JACQUEMIN | Strasbourg | 67000 | France |
| Hélène STURCHLER | Strasbourg | 67000 | France |
| Joël ETIENNEZ | Strasbourg | 67000 | France |
| Judah TOLEDANO | Strasbourg | 67000 | France |
| Nathan ABENHAIM | Strasbourg | 67000 | France |
| Patrick KORMANN | Strasbourg | 67000 | France |
| Philippe MARMOR | Strasbourg | 67000 | France |
| Roland BENEDIC | Strasbourg | 67000 | France |
| Véronique PEREZ | Strasbourg | 67000 | France |
| Maxime BOUMANDIL | Strasbourg | 67100 | France |
| Hervé MOREL | Tilly-sur-Seulles | 14250 | France |
| Bernard CLARY | Trèbes | 11800 | France |
| Jacques GRAVES | Trèbes | 11800 | France |
| Christian GIRARD | Uchaud | 30620 | France |
| Eric LIOTARD | Uchaud | 30620 | France |
| Olivier CHAIX | Uzès | 30700 | France |
| François BAYLE | Valleraugue | 30570 | France |
| Philippe BOISSON | Villé | 67220 | France |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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